Headache and Pain Syndromes

Atogepant Outperforms Topiramate in Head-to-Head Migraine Prevention Study

Jaymin Kang, PharmD
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Publish Date
Findings showed 12.1% of atogepant-treated patients discontinued treatment due to adverse events compared with 29.6% of topiramate-treated patients.

Topline results were announced from a phase 3 trial evaluating atogepant vs topiramate in adults with a history of 4 or more migraine days per month.

Atogepant, an oral calcitonin gene-related peptide (CGRP) receptor antagonist, is currently approved under the brand name Qulipta® for the preventive treatment of migraine in adults. The randomized, double-blind, phase 3 TEMPLE study (ClinicalTrials.gov Identifier: NCT05748483) evaluated the tolerability, safety, and efficacy of atogepant vs topiramate, an anticonvulsant, in 545 adults with a history of 4 or more migraine days per month.

The trial consisted of 2 periods: an initial 24-week double-blind treatment period, where study participants were randomly assigned to receive atogepant 60mg once daily or the highest tolerated dose of topiramate (50mg, 70mg, or 100mg/day); and a 52-week open-label treatment period, where eligible participants received atogepant 60mg once daily. 

The primary endpoint was the percentage of patients who discontinued the study due to adverse events during the 24-week double-blind treatment period. 

Findings showed significantly fewer discontinuations due to adverse events with atogepant compared with topiramate (12.1% vs 29.6%; relative risk, 0.41 [95% CI, 0.28-0.59]; P <.0001). Regarding efficacy, 64.1% of atogepant-treated patients achieved at least a 50% reduction in mean monthly migraine days during months 4 to 6 in the double-blind treatment period vs 39.3% of topiramate-treated patients (P <.0001). The trial also met all additional secondary endpoints.

“These TEMPLE data affirm recommendations from the American Headache Society and International Headache Society, highlighting the role of CGRP pathway inhibitors as first-line preventive treatment options for migraine,” said Roopal Thakkar, MD, executive vice president, research and development, chief scientific officer, AbbVie.

Full results from the trial will be presented at an upcoming medical meeting. 

This article originally appeared on MPR

References:

AbbVie announces new data demonstrating atogepant (Qulipta®/Aquipta®) achieves superiority across all endpoints in phase 3 head-to-head study compared to topiramate for migraine prevention. News release. AbbVie. June 18, 2025. https://www.prnewswire.com/news-releases/abbvie-announces-new-data-demonstrating-atogepant-qulipta–aquipta-achieves-superiority-across-all-endpoints-in-phase-3-head-to-head-study-compared-to-topiramate-for-migraine-prevention-302484421.html.